Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
High |
Report: “randomized using a computer generated randomization sheet”
Registry: "Method of Generating Random Sequence - Computer generated randomization; Method of Concealment - Case Record Numbers" Comment: Allocation sequence random. Allocation concealment probably not concealed. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics. Hence, no information on whether deviations arose due to trial context. Appropriate method of analysis used to estimate the effect of assignment to intervention; participants analyzed according to randomized assignment. Risk assessed to be some concerns for outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 60 patients randomized; 60 patients analyzed.
Data available for entire population. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study. Mortality and viral negative conversion are observer-reported outcomes not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Clinical improvement (defined as hospital discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcome: Clinical improvement (D28). |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The trial registry was available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
High |